A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

Description

The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

Conditions

DLBCL

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Study Overview

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Study Details

Study overview

The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

Condition
DLBCL
Intervention / Treatment

-

Contacts and Locations

Rochester

University of Rochester, Rochester, New York, United States, 14642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Previously untreated limited stage non bulky DLBCL; defined as limited stage by routine staging criteria in lymphoma involving FDG-PET and bone marrow biopsies (the Lugano criteria)\[21\]
  • * Patients with grade 3B follicular lymphoma and transformed indolent lymphoma are included
  • * Ages ≥ 18
  • * Measurable disease, assessable by radiographic examination with FDG-PET showing involvement
  • * Access to archived or fresh/frozen tumor biopsies
  • * No uncontrolled medical comorbidities
  • * Adequate cardiac function (EF \> or equal to 50%), no unstable angina
  • * Adequate renal function (GFR \> 60)
  • * Adequate liver function (liver function tests should be no greater than 2 x upper limit of normal) including normal bilirubin levels, no greater than 2 x upper limit of normal unless patient has a history of Gilbert's disease
  • * Adequate marrow reserves as indicated by complete blood count in the judgment of the treating investigator
  • * Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding
  • * Bulky disease greater than 10 cm in any dimension

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester,

Carla Casulo, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

2026-06-01